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Public Inspection

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the current document as it appeared on Public Inspection on
06/02/2014 at 08:45 am.

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Start Preamble

AGENCY:

Federal Trade Commission.

ACTION:

Proposed Consent Agreement.

SUMMARY:

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Order to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.

DATES:

Comments must be received on or before June 27, 2014.

ADDRESSES:

Interested parties may file a comment at https://ftcpublic.commentworks.com/​ftc/​lornameadconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Lornamead, Inc.—Consent Agreement; File No. 122 3255” on your comment and file your comment online at https://ftcpublic.commentworks.com/​ftc/​lornameadconsent by following the instructions on the web-based form. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for May 28, 2014), on the World Wide Web, at http://www.ftc.gov/​os/​actions.shtm.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before June 27, 2014. Write “Lornamead, Inc.—Consent Agreement; File No. 122 3255” on your comment. Start Printed Page 31940Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/​os/​publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).[1]
Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/​ftc/​lornameadconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/​#!home, you also may file a comment through that Web site.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before June 27, 2014. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/​ftc/​privacy.htm.

Analysis of Proposed Consent Order To Aid Public Comment

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing consent order from Lornamead, Inc. (“respondent”). The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

This matter involves respondent's advertising, marketing, and sale of a line of products including “Lice Shield Shampoo & Conditioner in 1,” “Lice Shield Leave In Spray,” and “Lice Shield Gear Guard” (collectively, “Lice Shield products”). Respondent marketed Lice Shield products in retail stores and on the Internet. According to the FTC's proposed complaint, respondent promoted Lice Shield products, which contain essential oils such as citronella, as a way to avoid, or to reduce the risk of, getting a head lice infestation (“pediculosis”). Lice Shield products are intended strictly as a means to deter lice, and not as a means to treat an existing head lice infestation. These products do not kill head lice or their eggs.

The proposed complaint alleges that respondent made several claims in various advertisements regarding the efficacy of Lice Shield products to deter lice, including that applying the products to hair or head gear: prevents head lice infestations; decreases the likelihood of an infestation by over 80%; dramatically reduces the likelihood of an infestation during an outbreak; or reduces the likelihood of an infestation during an outbreak. Respondent also allegedly represented that Lice Shield products are more effective when consumers use both the shampoo and the leave-in spray. The proposed complaint alleges that these claims are unsubstantiated and thus violate the FTC Act. Further, the proposed complaint alleges that respondent represented, in various advertisements, that scientific tests prove that, when used as directed, Lice Shield products will significantly reduce the likelihood or chance of a head lice infestation. The complaint alleges that this claim is false and thus violates the FTC Act.

The proposed consent order contains provisions designed to prevent respondent from engaging in similar acts or practices in the future. Part I of the order prohibits respondent from representing that use of any drug, cosmetic, or pesticide is effective in: (a) Preventing pediculosis, (b) eliminating or reducing the risk of pediculosis by a specific percentage or amount, or (c) repelling all lice, or a specific percentage or amount of lice from a person's head, unless the representation is non-misleading, and, at the time it is made, respondent possesses and relies upon competent and reliable scientific evidence that substantiates that the representation is true. For purposes of this Part I, competent and reliable scientific evidence shall consist of at least one adequate and well-controlled human clinical study of the product, or of an essentially equivalent product, that conforms to an acceptable design and protocol and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.

Part II of the proposed order prohibits any representation, other than those covered under Part I, that use of any drug, cosmetic, or pesticide, will reduce the risk of a head lice infestation or repel lice, unless the representation is non-misleading, and, at the time of Start Printed Page 31941making such representation, respondent possesses and relies upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence means tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons, and that are generally accepted in the profession to yield accurate and reliable results.

Part III of the proposed order prohibits any representation, other than those covered under Part I, about the health benefits of any drug, cosmetic, or pesticide, unless the representation is non-misleading, and at the time of making such representation, the respondent possesses and relies upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence means tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons, and that are generally accepted in the profession to yield accurate and reliable results.

Part IV of the proposed order addresses the allegedly false claim that scientific tests prove that use of Lice Shield products significantly reduces the risk or likelihood of a head lice infestation. Part IV prohibits respondent from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, when advertising any drug, cosmetic, or pesticide.

Part V of the proposed order states that the order does not prohibit respondent from making representations for any drug that are permitted in labeling for that drug under any tentative or final standard promulgated by the Food and Drug Administration (“FDA”), or under any new drug application approved by the FDA.

Part VI of the proposed order requires respondent to pay five hundred thousand dollars ($500,000) to the Commission. This payment shall be deposited in the United States Treasury as disgorgement.

Parts VII, VIII, IX, and X of the proposed order require respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements; to provide copies of the order to its personnel; to notify the Commission of changes in corporate structure that might affect compliance obligations under the order; and to file compliance reports with the Commission. Part XI provides that the order will terminate after twenty (20) years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.

Start Signature

By direction of the Commission.

Donald S. Clark,

Secretary.

End SignatureEnd Supplemental Information

Footnotes

1.
In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c).